Rizatriptan Benzoate's Novel Formulation for the Treatment of Acute Migraines Receives FDA Approval

IntelGenx Corp, the firm with exclusive commercialization rights, said in a press release that the US Food and Drug Administration has approved Rizafilm VersaFilm, an oral thin film formulation of rizatriptan benzoate, for the treatment of acute migraine.

This recently authorized medication has a film formulation of the 5-HT1 receptor antagonist that dissolves in the mouth and is intended to be bioequivalent to Merck's Maxalt-MLT, a medication that also contains an oral disintegrating version of rizatriptan.

With the FDA's approval of Rizafilm, another acute migraine therapy option is now accessible. This alternative may provide quick migraine relief and improvement, particularly for those who suffer nausea.

A single-dose, randomized, open-label, pivotal research comparing the bioavailability of Rizafilm 10 mg, Maxalt-MLT 10 mg oral disintegrating tablets, and Maxalt-Lingua 10 mg orodispersible tablets in 30 healthy volunteers determined the treatment's bioequivalence. Toronto, Ontario, Canada's Biopharma Services oversaw the study's execution. Late in 2018, IntelGenx launched the equivalent.2

The objective of the research was to evaluate the product's safety and bioequivalence to a top antimigraine medication using industry-recognized pharmacokinetic measurements, including peak plasma concentration (Cmax) and area under the curve (AUC). The study's findings showed that the product was safe and that its three parameters—Cmax, AUC(0-t), and AUC(0-infinity)—all fell within the approved 80 to 125 range for bioequivalency.

For the sole purpose of commercializing Rizafilm in the US, IntelGenx and Gensco entered into a binding license, development, and supply agreement in December 2018.1 Under the brand name Rizaport, the medication was previously approved in the European Union.

Prior to this, the FDA sent IntelGenx a Complete Response Letter (CRL) in March 2020 about their NDA for the Rizafilm VersaFilm formulation. The government had asked IntelGenx to give more details, but not a fresh bioequivalence analysis. In order to get the required clarity and decide the future actions, IntelGenx scheduled a meeting with the agency to talk through the CRL's remarks.

When the FDA issued a CRL regarding IntelGenx's resubmitted 505(b)(2) NDA for the treatment in April 2020, the company then announced a number of initiatives to assist it in addressing and responding to the FDA's request. In May 2020, the FDA approved IntelGenx's request for a Type A meeting to discuss its treatment, scheduled for June 10, 2020.

Following the meeting, the company gave an update and asked the FDA for clarification on the Chemistry, Manufacturing, and Controls (CMC) data needed for the NDA to be remitted. In response to the CRL's declaration that it could not accept IntelGenx's application in its existing form in October 2022, the company filed a response. The FDA approved the Class 2 response for consideration in November 2022 and established a revised PDFUA target action date.

This medicine has now been added to a growing list of novel migraine treatment choices that have received FDA clearance in the last five years, along with a number of other additional formulations of medications designed to overcome administration difficulties. Even as recently as last month, the FDA approved zavegepant nasal spray (Zavzpret; Pfizer) for the short-term treatment of adult migraine with or without aura. That treatment evolved into the first and only nasal spray for migraine sufferers that targets the calcitonin gene-related peptide (CGRP) receptor.

REFERENCES -

1. IntelGenx Announces FDA Approval of RIZAFILM® for the Treatment of Acute MigrainePartner Gensco® Pharma preparing to commercially launch RIZAFILM® across the United States as soon as is practicable. News release. IntelGenx. April 17, 2023. Accessed April 17, 2023. https://www.biospace.com/article/releases/intelgenx-announces-fda-approval-of-rizafilm-for-the-treatment-of-acute-migrainepartner-gensco-pharma-preparing-to-commercially-launch-rizafilm-across-the-united-states-as-soon-as-is-practicable/

2. IntelGenx Announces Successful Results from RIZAPORT® Bioequivalence Study. News release. IntelGenx. September 24, 2018. Accessed April 17, 2023. https://www.intelgenx.com/newsrooms/newsrooms1/11-2018/288-intelgenx-announces-successful-results-from-rizaport-bioequivalence-study.html?highlight=WyJiaW9lcXVpdmFsZW5jZSJd

3. IntelGenx Announces Adjusted VersaFilm Business Strategy, Next Steps for RIZAPORT VersaFilm Program. News Release. IntelGenx. Published April 6, 2020. Accessed April 14, 2023. https://www.globenewswire.com/news-release/2020/04/06/2012083/0/en/IntelGenx-Announces-Adjusted-VersaFilm-Business-Strategy-Next-Steps-for-RIZAPORT-VersaFilm-Program.html

4. IntelGenx Confirms Type A Meeting with the FDA Regarding RIZAPORT VersaFilm. News Release. Published May 27, 2020. Accessed April 14, 2023. https://www.globenewswire.com/news-release/2020/05/27/2039346/0/en/IntelGenx-Confirms-Type-A-Meeting-with-the-FDA-Regarding-RIZAPORT-VersaFilm.html

5. IntelGenx Provides Update on RIZAPORT VersaFilm NDA Resubmission Process Following Type A Meeting with the FDA. Published June 11, 2020. Accessed April 14, 2023. https://www.globenewswire.com/news-release/2020/06/11/2046819/0/en/IntelGenx-Provides-Update-on-RIZAPORT-VersaFilm-NDA-Resubmission-Process-Following-Type-A-Meeting-with-the-FDA.html

6. IntelGenx Submits Response to CRL from FDA for RIZAPORT VersaFilm. News Release. IntelGenx. Published October 18, 2022. Accessed April 12, 2023. https://www.globenewswire.com/en/news-release/2022/10/18/2536340/0/en/IntelGenx-Submits-Response-to-CRL-from-FDA-for-RIZAPORT-VersaFilm.html

7. IntelGenx Receives FDA PDUFA Date for RIZAFILM. News Release. IntelGenx. Published November 22, 2022. Accessed April 14, 2023. https://www.globenewswire.com/en/news-release/2022/11/22/2560714/0/en/IntelGenx-Receives-FDA-PDUFA-Date-for-RIZAFILM.html